测试与安全

quality-manager-qms-iso13485

alirezarezvani/…e-skills

ISO 13485 Quality Management System implementation and maintenance for medical device organizations. Provides QMS design, documentation control, internal auditing, CAPA management, and certification support. Use when working with medical device quality systems, preparing for ISO 13485 audits, managing regulatory compliance documentation, setting up corrective actions, or building audit preparation programs. Useful for quality management, audit preparation, regulatory compliance, medical device documentation, and corrective action workflows.

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安装命令

npx skills add https://github.com/alirezarezvani/claude-skills --skill quality-manager-qms-iso13485

SKILL.md

Quality Manager - QMS ISO 13485 Specialist

ISO 13485:2016 Quality Management System implementation, maintenance, and certification support for medical device organizations.


Table of Contents


Quality Manager - QMS ISO 13485 Specialist

ISO 13485:2016 Quality Management System implementation, maintenance, and certification support for medical device organizations.


Table of Contents